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Ulcerative ColitisTOFASTNCT04424303

Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

An observational study of Ulcerative Colitis, run by Pfizer at 38 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Tofacitinib
How many people
152 participants
Where
38 sitesFrance
Study dates
4 Dec 2020to 8 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with moderate to severe Ulcerative Colitis initiating tofacitinib treatment as per the French Summary of product characteristics (SmPC)

Who may be able to join

  • Patients of 18 years old or above
  • Patients with confirmed diagnosis of moderate to severe ulcerative colitis
  • Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC
  • Patients informed about the study procedures and receiving an information letter signed by the investigator

Who cannot join

  • Patients who have already received tofacitinib treatment before baseline
  • Patients that fulfill any of the contrindications according to the latest version of the SmPC

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • Clinique de l Europe

    Amiens, 80090

  • Hopital Sud

    Amiens, 80480

  • Hopital Jean Minjoz

    Besançon, 25003

  • Hopital de La Cote de Nacre

    Caen, 14027

  • Centre Hospitalier de Cahors

    Cahors, 46005

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

  • Hopital Trousseau

    Chambray-lès-Tours, 37171

  • Hopital D'Estaing

    Clermont-Ferrand, 63100

  • Aphp - Hopital Beaujon

    Clichy, 92118

  • Ch Intercommunal de Creteil

    Créteil, 94010

  • Ch Dunkerque

    Dunkirk, 59385

  • Hopital Albert Michallon

    La Tronche, 38700

  • Ch Bicetre

    Le Kremlin-Bicêtre, 94275

  • CH Le Mans

    Le Mans, 72037

  • Ch Emile Roux

    Le Puy-en-Velay, 43012

  • Hopital Claude Huriez

    Lille, 59037

  • Ch Saint Joseph Saint Luc

    Lyon, 69365

  • Ch Montfermeil

    Montfermeil, 93370

  • Clinique Beau Soleil

    Montpellier, 34070

  • Hopital Saint Eloi

    Montpellier, 34295

  • Chu Nantes

    Nantes, 44004

  • Clinique Jules Verne

    Nantes, 44014

  • Hopital de L'Archet

    Nice, 06202

  • Hopital Caremeau

    Nîmes, 30029

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Aphp - Hopital Saint Louis

    Paris, 75466

  • Groupe Hospitalier Saint Joseph

    Paris, 75674

  • Chu Bichat Claude Bernard

    Paris, 75877

  • Chu de Bordeaux - Hopital Haut Leveque

    Pessac, 33600

  • CHU LYON

    Pierre-Bénite, 69495

  • Ch Annecy Genevois

    Pringy, 74374

  • Chu Rennes

    Rennes, 35033

  • Hopital Nord

    Saint-Priest-en-Jarez, 42277

  • Clinique Pasteur

    Toulouse, 31076

  • Hopital Rangueil

    Toulouse, 31403

  • Ch Valence

    Valence, 26953

  • Ch Valenciennes

    Valenciennes, 59322

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69694

Other trials in France

About this study

Official title: Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

Read the detailed description

TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

Being tested
Tofacitinib
Keywords
Ulcerative Colitis, Tofacitinib, France, Real world data
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TofacitinibDrug

    Observational study

Study groups in NCT04424303
Study groupRoleWhat they receive
Patients prescribed tofacitinibPatients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC).
Receives: Drug: Tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.

    The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period.

    Clinical benefit at year is defined on the basis of symptomatic remission evaluated with the PRO2 score ≤1 (absence of rectal bleeding and a stool frequency score between 0 and 1)*. Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used oal corticosteroids for UC, (regardless of the treatment duration) during the 3 months preceding the end of the observation period.

    The clinical benefit of tofacitinib is independent of the administration or not of 5-ASA, or corticosteroids (not complying with the above definition) during the observation period (between 0 and 1 year).

    Measured: Week 52

Secondary outcomes (16)

  1. Proportion of patients with clinical benefit of tofacitinib at 2 years

    Measured: week 104

  2. Predictors of the clinical benefit at one year identified from the available baseline data

    Measured: Week 52

  3. Proportion of patients in clinical remission and still receiving tofacitinib

    Clinical remission is defined as partial Mayo score (PMS) <2

    Measured: Week 52 and Week 104

  4. Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC)

    Measured: Week 52 and week 104

  5. Proportion of patients with short-term clinical response for patients still treated with tofacitinib

    Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).

    Measured: Approximately week 8 and 16

  6. Proportion of patients with biological response during the observation period

    Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)

    Measured: Week 52 and 104

  7. Proportion of patients with endoscopic improvement during the observation period

    endoscopic improvement is defined as endoscopic subscore of 0 or 1

    Measured: Week 52 and 104

  8. Proportion of patients in sustained clinical remission

    Clinical remission is defined as partial Mayo score (PMS) <2 at 52 and 104 weeks

    Measured: Week 52 and 104

  9. Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction

    The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK)

    Measured: Week 8, 16, 24, 72, 52 and 104

  10. Proportion of patients with extraintestinal manifestations at each visit

    Measured: Week 8, 16, 24, 72, 52, 104

  11. Proportion of patients with a colectomy during study follow-up and time of occurrence

    Measured: Week 8, 16, 24, 72,52 and 104

  12. Characteristics of patients and UC, on the basis of all the data collected at baseline

    Measured: Week 104

  13. Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy

    (self-assessment by patients)

    Measured: 14 days

  14. Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years

    Measured: Week 52, Week 52 to week 104 and week 104

  15. Change in adherence to tofacitinib treatment during each visit

    Using MARS questionnaire

    Measured: Week 8, 16, 24, 72, 52, 104

  16. Proportion of patients with serious and non-serious adverse events.

    Measured: Week 8, 16, 24,72,52 and 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start4 Dec 2020
  3. Primary completion8 Dec 2025
  4. Study completion8 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04424303
Sponsor's protocol ID
A3921360
Other IDs
TOFAst study
Acronym
TOFAST
Status last verified
Jan 2026
First submitted
8 Jun 2020
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Pfizer at 38 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment. (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04424303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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